Storage of materials
AssigneeInhale Therapeutic Systems
InventorsFelix Franks, Ross Henry Hatley, Sheila Frances Mathias
Life of this patent
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Abstract
Materials which are not themselves storage-stable at room temperature are made suitable for storage by mixing them with a carrier substance and spray drying the resulting mixture so as to form particles containing both the material and the carrier substance in which the carrier substance is in an amorphous, i.e. glassy or rubbery, state. Formation of such a composition greatly enhances stability. The material stored may be a biological material such as an enzyme, the components of a chemical reaction such as reagents for carrying out an assay, or even viable biological cells.
Claims61
A storage-stable composition of spray-dried particles comprising:
- an active material selected from the group consisting of proteins, peptides, nucleosides, nucleotides, dinucleotides, oligonucleotides, and viable biological cells, and
- a protein or protein hydrolysate carrier substance that is water-soluble or water-swellable, and that, on its own, is able to exist in a glassy state with a glass transition temperature (Tg) above 20° C.,
- wherein (i) the particles have a Tg above 30° C., (ii) the carrier is in a glassy state, and (iii) a storage stable composition is characterized as one which, when stored at ambient temperature for a period of 30 days, maintains at least about 90% of its initial activity or chemical identity measured directly after spray drying.
A storage-stable composition of spray-dried particles comprising:
- an active material selected from the group consisting of nucleosides, nucleotides, dinucleotides, oligonucleotides, and viable biological cells, and
- a carrier substance that is water-soluble or water-swellable, and that, on its own, is able to exist in a glassy state with a glass transition temperature (Tg) above 20° C.,
- wherein (i) the particles have a Tg above 30° C., (ii) the carrier is in a glassy state, and (iii) a storage stable composition is characterized as one which, when stored at ambient temperature for a period of 30 days, maintains at least about 90% of its initial activity or chemical identity measured directly after spray drying.
A storage-stable composition of spray-dried particles comprising:
- an active material selected from the group consisting of proteins, peptides, nucleosides, nucleotides, dinucleotides, oligonucleotides, and viable biological cells, and
- a carrier substance that is water-soluble or water-swellable, and that, on its own, is able to exist in a glassy state with a glass transition temperature (Tg) above 20° C.,
- wherein (i) the particles have a Tg above 30° C., (ii) the carrier is in a glassy state, (iii) the composition has a moisture content from about 3% to 9% by weight, and (iv) a storage stable composition is characterized as one which, when stored at ambient temperature for a period of 30 days, maintains at least about 90% of its initial activity or chemical identity measured directly after spray drying.
Dependencies are inferred from the claim text.